Outsourcing in Clinical Trials New England 2021

Biography: Ken is the Director of Sponsored Research and Associate Professor at the Tufts Center for the Study of Drug Development, and Chairman of the Center for Information and Study on Clinical Research Participation, a non-profit organization that he founded to raise public and patient awareness of the clinical research enterprise. He is founder and owner of CenterWatch, and an owner and board member of the Metrics Champion Consortium. A well-known speaker at symposia, universities, and corporations, Ken has published extensively in peer-reviewed journals, books and in the trade press.  He has been an active DIA member for 25 years and has held board appointments in the private and public sectors.  Ken earned his MBA from Northwestern University.

Session Details: Measuring the Impact of the Pandemic on Drug Development Productivity and Performance 10-11-2021, 2:30 pm View In Agenda

Biography: Bonnie Bain, PhD, is the Global Head and EVP of Healthcare Operations and Strategy. Bonnie has over 20 years’ experience in the healthcare sector and a proven track record of developing innovative solutions on both the client and agency sides of the business. Bonnie was GlobalData Healthcare’s first Western analyst, and under her leadership, the company launched a number of premium syndicated reports, analytical tools, and databases in the pharmaceuticals and medical devices space. Prior to GlobalData, Bonnie was Vice President and Global Research & Analysis Director for Informa’s Pharma Division, which includes Datamonitor Healthcare, Scrip Group, and Business Insight. Bonnie also worked for several years at Decision Resources as an Analyst and Project Manager. On the client side of the industry, Bonnie worked for several years as a Senior Manager in Marketing Strategy and Analytics at Boston Scientific, where her work contributed to the successful commercialization of the first ever Access and Visualization Platform at the company. Bonnie has a PhD in Biochemistry and Molecular Biology from Purdue University and completed a Post-Doctoral Fellowship in Molecular Pharmacology at the University Of Miami School Of Medicine. She also has a graduate certificate in Applied Management Principles from Purdue University Krannert School of Management.

Session Details: Clinical Trial Technology 09-11-2021, View In Agenda

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Session Details: Digital Transformation in Clinical Trials-Patient Recruitment and Retention 09-11-2021, 9:00 am View In Agenda

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Kiran Dole started her pharma career with Novartis Pharmaceuticals in NJ, where she joined as a Clinical Trial Leader in the Translational Sciences group, designing and overseeing early phase clinical studies. She transitioned to NIBR in 2008 where the focus of her work evolved to the identification and implementation of novel technologies to design more data-rich, and patient-centric trials. Her passion for innovative technologies has led her to a career at Pear Therapeutics as the Director of Clinical Operations.   Kiran holds a PharmD from SUNY Buffalo as well as a Bachelors in Biochemistry from the University of Toronto .

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Biography: Harry Barnett Harry is the co-founder and Executive Chairman of Lubris BioPharma, a clinical-stage biotech company developing a proprietary version of the novel, ubiquitous human protein, PRG4, for use in multiple indications.  Novartis owns rights to Lubris’ technology for ophthalmology. Harry’s two-decade life science career includes: (i) co-founding and executive management roles at three life science companies and two CROs; (ii) incubating, partnering and licensing successfully a wide array of pharmaceutical products and technologies including Pepcid Complete®, the OTC hearburn remedy sold by J&J, and; (iii) innovating multi-center, clinical trial processes using techniques that have been adopted as industry standard.  Prior to his transition to life science and biotech, Harry was a transactional business lawyer in private practice at DLA Piper in San Diego, and later at Faneuil Advisors, Inc., an investment advisory firm based in Boston where he served as General Counsel and Executive Vice President.

Session Details: Q&A Session - Early Phase Trials: How much attention should be focused on commercialization? 09-11-2021, 10:30 am Clinical Trial Innovation 09-11-2021, PANEL DISCUSSION - Early Phase Start-ups post pandemic: Discussing how to start a resilient trial in a disrupted world 09-11-2021, 2:30 pm Leaders Panel Discussion: Exploring what lessons learnt from the COVID-19 Pandemic the clinical trials industry should use moving forwards 10-11-2021, 1:15 pm View In Agenda

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Session Details: Q&A Session - Early Phase Trials: How much attention should be focused on commercialization? 09-11-2021, 10:30 am PANEL DISCUSSION - Early Phase Start-ups post pandemic: Discussing how to start a resilient trial in a disrupted world 09-11-2021, 2:30 pm “To Outsource or Not to Outsource?” That is the Question – A Panel Discussion 10-11-2021, 9:00 am View In Agenda

Biography: Hollie Schmidt is the VP of Scientific Operations at Accelerated Cure Project for Multiple Sclerosis. She co-chairs the Research Committee of iConquerMS™, a research cohort established to perform and support patient-centered research in MS. She also founded and leads the MS Minority Research Engagement Partnership Network, a multi-stakeholder initiative aimed at increasing racial and ethnic diversity in MS research studies.

Session Details: Exploring Patient Diversity in Clinical Trials: Tackling the Under-Representation Problem 09-11-2021, 12:00 pm View In Agenda

Biography: Adrian Orr is the Executive Director of Clinical Affairs at Anika Therapeutics, Inc in Bedford, MA. Adrian has previously worked in a range of small to medium-sized medical device and biologics companies including Gyrus Medical, Serica Technologies, and Haemonetics. He has focused on re-structuring and developing clinical teams to tackle technically challenging surgical and biologics trials. Adrian’s current focus is on joint preservation and tissue regeneration in orthopedics. His talk today will center on the use of eDiaries in clinical research.

Session Details: CASE STUDY: Diving into the sponsor experience of eDiary use in clinical trials 09-11-2021, 12:00 pm View In Agenda

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Session Details: Building the bridge from R&D to Early Phase Trials 09-11-2021, 12:00 pm PANEL DISCUSSION - Early Phase Start-ups post pandemic: Discussing how to start a resilient trial in a disrupted world 09-11-2021, 2:30 pm View In Agenda

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Biography: Strategic & technical leader applying machine learning, data mining, visualization and analytics skills to solve key data science problems. Data science is a hybrid field integrating computer science, visualization, statistics, and business knowledge. The standard skill set emphasizes breadth over depth yet both are critical: ● Advise and guide the technical direction of Pfizer's machine learning, deep learning and AI entries into natural language processing, image processing, and predictive modeling ● Harvard University lecturer teaching the Master's software engineering capstone and the graduate level, machine learning and data mining courses ● Analytics researcher: developed ~30 novel visualization and analytical tools in use at Pfizer ● Ph.D. in computer science emphasizing artificial intelligence and machine learning ● Master's degrees: software engineering, applied statistics, applied linguistics, image processing and biology ● Statistician: primary site statistician for 10 years supporting up to 200 scientific researchers ● Broad industry experience including pharmaceuticals, defense, text mining, and education

Session Details: PATIENT RECRUITMENT CASE STUDY: An innovative open-source iPhone app designed for patient recruitment 09-11-2021, 1:30 pm PANEL DISCUSSION Is the pharma industry still too conservative with wearable tech? 09-11-2021, 3:45 pm View In Agenda

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Session Details: Navigating Outsourcing for Gene Therapy Trials 09-11-2021, 2:30 pm View In Agenda

Biography: Dr. Sherris has over 30 years’ experience in translational medicine involving basic research, pharmaceutics and diagnostics.  Dr. Sherris has been a successful serial entrepreneur developing biotechnology companies from the ground up, devising corporate strategy, enacting programs and carrying companies through funding and acquisition.  Dr. Sherris prides himself as a “roll up your sleeves” CEO, entrepreneur, business development officer, drug developer and scientist, not simply a delegator. Dr. Sherris has worked with venture capital companies, investment banks and angel investors where he has advised and raised well over $100 million for biotech companies.  Dr. Sherris has been employed by pharmaceutical and biotechnology companies to manage external (academic groups and contract research organizations) and internal (directly manage, augment and expand internal scientific programs) research and development. Dr. Sherris has been a frequently invited guest speaker at biopharmaceutical business and scientific conferences, a published author and holder of patents in a wide range of therapeutic areas including oncology, ophthalmology, dermatology, neurology, gene therapy and infectious disease.  Dr. Sherris has held positions of increasing responsibility in public and private companies.  Dr. Sherris has developed drugs from the bench to the clinic, partnered technologies to pharmaceutical companies and raised capital for companies at the triple digit million dollar levels.

Session Details: Ensuring Top Quality Project Teams from Vendors from a Small Biotech’s Point of View 09-11-2021, 4:45 pm Discussing novel therapeutic modality, which through a gene vector, can induce both a direct anti-tumor effect and a immune mediated one 10-11-2021, 11:30 am Leaders Panel Discussion: Exploring what lessons learnt from the COVID-19 Pandemic the clinical trials industry should use moving forwards 10-11-2021, 1:15 pm View In Agenda

Biography: Dr. Missling, President and CEO of Anavex, has over 20 years of healthcare industry experience within large pharmaceutical companies, the biotech industry and investment banking. Prior to joining Anavex®, he served as the Chief Financial Officer of Curis and ImmunoGen. In addition, at Aventis (now Sanofi),  Dr. Missling worked as head of financial planning on all aspects of financial strategy and M&A. His career experience also includes working as an investment banker in the healthcare practice at Deutsche Bank, serving pharmaceutical, biotech, and diagnostic companies, as well as serving as the head of healthcare investment banking at Brimberg & Co. in New York. Dr. Missling has an MS and PhD from the University of Munich in Chemistry and an MBA from Northwestern University Kellogg School of Management.

Session Details: PANEL DISCUSSION Is the pharma industry still too conservative with wearable tech? 09-11-2021, 3:45 pm Clinical Trials for Rare Diseases: Challenges and Opportunities 10-11-2021, 10:30 am View In Agenda

Biography: Dr Daniel Klamer, Vice President of Business Development and Scientific Strategy of Anavex, has more than 15 years of experience in neuroscience and the orphan disease space, with acquisition, partnering and R&D experience in Europe and the USA. Prior to Anavex he worked at Retrophin and Neurosearch Sweden. At Neurosearch Sweden, Dr Klamer led and evaluated multiple discovery-phase neuropharmacological research products with an emphasis on strategic evaluation of preclinical and clinical development. Dr. Klamer earned his PhD in Pharmacology at The Sahlgrenska Academy at University of Gothenburg, Sweden, his MBA at Fordham Gabelli School of Business, and his Post-Doctoral training at the Department of Psychiatry, Yale University School of Medicine. In addition, Dr. Klamer holds a position as an Associate Professor at the Department of Pharmacology at The Sahlgrenska Academy at the University of Gothenburg.

Session Details: PANEL DISCUSSION Is the pharma industry still too conservative with wearable tech? 09-11-2021, 3:45 pm Clinical Trials for Rare Diseases: Challenges and Opportunities 10-11-2021, 10:30 am View In Agenda

Biography: Dr. Arkady Gusev is Global Head of Laboratory Excellence and Operations in Biomarker Development / Translational Medicine of Novartis Institute for Biomedical Research. In his current role he is responsible for the scientific and operational leadership of clinical biomarkers, assay outsourcing, sample operations, central laboratory set up and vendor management.  Previously, Arkady Gusev led the Business and Technology Operations units in the Department of Pharmacokinetics, Dynamics and Metabolism in Pfizer Global Research Division.   Arkady Gusev received his PhD (1992) in mass spectrometry from Institute of Space Research, Russian Academy of Sciences. Following his PhD, he joined the Department of Chemistry, University of Pittsburgh as a postdoc and held a Research Assistant Professor position in the Department of Chemistry at Vanderbilt University before joining the industry in 1997. Arkady Gusev is the author and co-author of 50+ peer-reviewed publications in different areas of bioanalytical technologies, bioanalysis, biomarkers and clinical operations.

Session Details: NOVARTIS DISCUSSION - Diving into the New Era of Patient Centric Micro-Sampling Devices Which Can Fit into New Technologies: How Have These Been Influenced by COVID & the DCT Movement? 09-11-2021, 2:30 pm View In Agenda

Biography: Prasanna Rao is an AI practitioner and Industry Thought Leader whose current role is Head of Artificial Intelligence and Data Science for Data Management at Pfizer. He has 30 years of experience in Information technology and Analytics, with 10+ years in Healthcare and Life Sciences. In his previous role as a Watson Solution Architect at IBM, he was instrumental in implementing many different AI systems from idea to implementation with various clients. In his current role, he works with various stakeholders, vendors, business SMEs, Machine Learning developers, and Data Scientists to deliver innovation and drive adoption of AI. He has presented at several industry conferences including SCDM, DIA and SCOPE.

Session Details: PFIZER CASE STUDY: Application of NLP/ML for saving valuable time during data reconciliation of COVID Vaccine studies 10-11-2021, 9:00 am View In Agenda

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Session Details: Q&A / Audience Discussion Session: 5 Tips for Staying in Control of your Medical Device Trial 10-11-2021, 9:30 am FIRESIDE CHAT: The revolution in FemTech and the Importance of Women’s Health Equity 10-11-2021, 10:30 am View In Agenda

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Session Details: “To Outsource or Not to Outsource?” That is the Question – A Panel Discussion 10-11-2021, 9:00 am Exploring the Importance of Including the Quality Assurance Perspective in Outsourcing Dilemmas 10-11-2021, 11:30 am View In Agenda

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Session Details: “To Outsource or Not to Outsource?” That is the Question – A Panel Discussion 10-11-2021, 9:00 am View In Agenda

Biography: John Seman is a Pharmaceutical Executive with a consistent track record of building teams, solving problems, adapting to changing markets, and establishing long term growth strategies.     Mr. Seman began his career in global life science corporations working for E. R. Squibb & Sons and multiple divisions of Johnson & Johnson, holding various management positions in sales, marketing and business development.  During his tenure at Squibb, he was a team member responsible for the introduction a new cardiovascular drug that achieved highest first year sales in company history.  At Johnson & Johnson, he managed a portfolio of eight biotech products in various stages of pre-clinical and clinical development, and actively participated in the licensing and acquisition of anti-infective pharmaceutical products.  He served as Vice President of Marketing at the central laboratory division of Corning Pharmaceutical Services where he was responsible for expansion of services into the European market, and for developing an innovative marketing strategy to increase profitability with a growing base of top tier pharma customers.     For the past 20 years, Mr. Seman has been a serial entrepreneur involved in multiple startups including:  A Founder of AVANTEC, an innovative technology based company focused on accelerating the receipt of clinical trial data from investigator sites, where he secured over $10M from multiple rounds of financing; CEO at HealthBridge, a reimbursement services company, where he tripled revenue and successfully positioned the company for a sale; CEO at PhysioGenix, a preclinical research company, where he secured seed funding from angel investors; and most recently licensed technology from universities for commercialization with ZOETIC Pharmaceuticals and REVITALE Pharma focused on expanded use of anti-virals.     Mr. Seman’s non-profit experience includes executive leadership of the Alosa Foundation, an independent medical education organization, where he secured multi-year contracts from the Commonwealth of Pennsylvania, the Commonwealth of Massachusetts and the District of Columbia public health departments for the dissemination of evidence based treatment strategies to primary care physicians.  He also served as the Founding CEO of Launch NY, an economic development organization serving the 27 counties of upstate New York, raising $7 million from the federal government and regional foundations.     Mr. Seman holds a Bachelor of Science degree in Pharmacy, and received a Master of Science degree with honors in Pharmaceutical Economics and Business Administration, from the Massachusetts College of Pharmacy. He is an active participant in industry associations, and continues to be sought after to present at national and regional life science conferences.  Mr. Seman also volunteers as a coach and mentor to aspiring life science entrepreneurs from the University at Buffalo, McMaster University, and Syracuse University to support their efforts to build companies, win business plan competitions, and secure financing.

Session Details: PANEL DISCUSSION: Is Repurposing Off-Patent Drugs a Viable Development Strategy? 10-11-2021, 9:30 am View In Agenda

Biography: Matthew Fedowitz is a life sciences industry lawyer who focuses his practice on achieving the business goals of clients. Matthew brings his legal insight and business instincts to bear for clients. He looks at issues from all perspectives to achieve the most effective and desired outcome for his clients. This is particularly important in today’s competitive business environment where legal strategy must fit within the business goals of a client. This includes patent portfolio development and strategic patent prosecution; counseling with regard to FDA regulatory issues and their intersection with intellectual property; litigation in federal district court; and inter partes proceedings before the Patent Trial and Appeal Board. Matthew was selected for inclusion in the IAM Patent 1000 – The World’s Leading Patent Practitioners, 2014-2021; Virginia Rising Stars, 2014-2015; Washington, D.C. Rising Stars, 2014-2015; and Washington, D.C. Super Lawyers in 2020-2021.

Session Details: PANEL DISCUSSION: Is Repurposing Off-Patent Drugs a Viable Development Strategy? 10-11-2021, 9:30 am View In Agenda

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Session Details: Outsourcing in Early Development: Planning for the Unknown 10-11-2021, 10:30 am View In Agenda

Biography: A strong proactive leader of groups within the Data Analysis and IT disciplines in the Healthcare industry sector. A managerial style based upon vast global experience, which incorporates a pragmatic approach to issue management together with a progressive attitude to create and successfully implement business driven strategic change initiatives within multicultural environments. Recent key achievements (1) Led a team that developed and implemented a Strategic systems approach to capitalise on the Clinical Data assets own by the Roche Product Development Group (2) Optimising the global sourcing solutions within the group by taking advantage of CRO, Contractors and Offshoring solutions. (3) Transitioned the programming group from being heads down programmers to Analysts who proactively provide and develop solutions for partners and customers

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Session Details: Leaders Panel Discussion: Exploring what lessons learnt from the COVID-19 Pandemic the clinical trials industry should use moving forwards 10-11-2021, 1:15 pm Speaker Hosted Discussion Session Working in the “New Normal”: What should the modern Clinical Trials Operations Team look like? 10-11-2021, 3:30 pm View In Agenda

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Biography: Amanda Hayden is an Executive Director of Clinical Operations at Eledon Pharmaceuticals, and has worked for over 20 years in the clinical operations field. Amanda started her career as a CRA with a small CRO, progressing to Lead CRA and Project and Program Management roles at Antigenics (now Agenus) and Millennium Pharmaceuticals (now Takeda). She then transitioned into Clinical Leadership positions at Lantheus Medical Imaging, and at Alkermes, where Amanda spent 8 years overseeing Study Start Up, Clinical Compliance, Clinical Systems and Disclosure and Technical Solutions. She has extensive prior monitoring and project management experience, with more than 10 years focused on Oncology trials. More recently, Amanda has spent significant time dedicated to large scale trial start-up, including global trial submissions and study launches in approximately 20 countries, as well as in overseeing ICH E6 R2 implementation and Inspection Readiness initiatives.

Session Details: PANEL DISCUSSION - Working Through Issues with Your CRO to Stay in Control of Your Study 09-11-2021, 3:45 pm View In Agenda

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Session Details: Case Study: Bringing a Combination Product to Market 10-11-2021, 9:00 am View In Agenda

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Session Details: FIRESIDE CHAT: The revolution in FemTech and the Importance of Women’s Health Equity 10-11-2021, 10:30 am View In Agenda

Biography: Dr. Isaac R. Rodriguez-Chavez is a biomedical leader with expertise in Infectious Diseases, Viral Immunology, Viral Oncology, and Vaccinology. His experience covers the entire life cycle of medical products from basic, preclinical, interventional clinical research (phase I – IV), non-interventional clinical research, and post-marketing studies. Currently, he is a Senior Vice President,  Scientific & Clinical Affairs, and Head, Global Strategy Center of for DCTs and Digital Medicine at ICON plc. Past positions include FDA, CDER Senior Officer for Clinical Research, Regulatory Compliance, and Policy Development modernizing clinical research through DCTs enabled by DHTs. He published numerous articles and has been an invited speaker in 100+ global conferences. He holds leadership roles at DiME, IEEE, DTRA, HCMA, Global Genes, and DIA Global Forum. He is also involved with and a member of 14 professional associations. He has a Ph.D. in Virology and Immunology; a M.S. in Microbiology; a M.H.S. in Clinical Research; and a B.S. in Biology. He completed two postdoctoral training specialties in viral immunology and viral oncology combined with clinical research at the National Institute on Aging and the National Cancer Institute of the National Institutes of Health.

Session Details: Breaking Traditional Trial Barriers with Innovation in Decentralized Clinical Trials Supported by Digital Health Technologies 09-11-2021, 11:30 am View In Agenda

Biography: Tiepu Liu, MD, PhD, is President of Global Biometrics at ClinChoice. He plans goals and strategies and manages organizational structure and operational standards and process. He leads experienced clinical development teams specialized in data management, biostatistics, and programming to provide high quality and timely services to global biopharmaceutical clients. Dr. Liu served as a Biostatistician and Epidemiologist at the UAB Comprehensive Cancer Center and led a Biostatistics and Epidemiology group at the University of Cincinnati. In his industry career, he has served as Director of Biostatistics at PPD, Executive Director of Statistics and Data Management at UBC, and Senior Director of Biostatistics at Graceway Pharmaceuticals and The Medicines Company. Dr. Liu has published over 100 scientific papers. He has worked with numerous Data Monitoring Committees (DMCs) in various capacities, including serving as a voting statistician member and coordinating and presenting frequently to DMCs. Dr. Liu has led numerous clinical development programs in various therapeutic areas. He served as core lead in gaining global approval and successful commercialization of Arestin (minocycline), Zyclara (imiquimod), and Kengreal (cangrelor) interacting with various regulatory agencies, including FDA, EMA, PMDA, and NMPA. Dr. Liu received his doctoral degree in Biostatistics and Epidemiology from the University of Alabama at Birmingham (UAB) after completing Medical and Public Health training at Tongji Medical University, China.

Session Details: Improving data and analysis operations through data science and technology innovation 09-11-2021, 2:00 pm View In Agenda

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Session Details: Current Landscape in Asia Pacific and the Potential for Driving Efficiencies Via Virtual Trial Solutions 09-11-2021, 9:30 am View In Agenda

Biography: Aditya is the Regional Director of Business Development at Novotech, the Asia Pacific specialist CRO. He has extensive experience helping sponsor companies make their trials a reality across a range of projects from first in human to phase iv.  

Session Details: Current Landscape in Asia Pacific and the Potential for Driving Efficiencies Via Virtual Trial Solutions 09-11-2021, 9:30 am “To Outsource or Not to Outsource?” That is the Question – A Panel Discussion 10-11-2021, 9:00 am View In Agenda

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Bill Cooney founded MedPoint Digital in 1990. As President and CEO, he continues to lead the strategic growth of a world-class digital services company to the medical industry. Prior to launching MedPoint, Bill was on the Executive Committee and helped start-up Discovery International, the medical education arm of Publicis Healthcare.

In the 1980s, Bill worked in sales and marketing positions at Wyeth and Abbott. He was Business Unit Manager for the Depakote brand at Abbott, and helped form the first telemarketing sales department at Abbott.

Throughout his career, Bill has spoken at numerous healthcare industry events and bylined articles in pharmaceutical trade journals on topics ranging from medical education to research training and digital technology. Bill is Chairman of the Board of Directors for Healthcare Consultants International, Inc., a company providing training and consulting services to healthcare providers and facilities. Bill holds an M.B.A. from the Fisher College of Business of The Ohio State University and a B.A. from The University of Virginia.

Session Details: Think Synch/aSynch 10-11-2021, 2:00 pm View In Agenda

Biography: Executive intrapreneur turned digital health entrepreneur, my career includes nearly 20 years leading global drug development, clinical research, and decentralized clinical trials (DCTs) for life science organizations. As CEO of THREAD, I lead our global organization in achieving our 1/5/30 mission to modernize clinical research by offering biopharma and CRO customers one (1) comprehensive platform that is five (5) times more inclusive and makes research 30% more efficient. After co-founding and growing THREAD, we were acquired in 2019 by JLL Partners and Water Street with strategic investment for continued growth and focus on accelerating drug development for our customers. Named one of the Top 100 Influencers in Digital Health, I also provide expertise and execution experience in digital health, clinical research innovation, and DCTs. Learn more about John at www.linkedin.com/in/johnreites

Session Details: Best Practices for Global DCT Adoption 09-11-2021, 4:15 pm View In Agenda

Biography: Jay is responsible for managing the creation and design of product features and new capabilities for Trial Interactive. Jay brings over 25 years of product management, consulting, and engineering experience across verticals such as life sciences, enterprise software, healthcare, government, entertainment, and manufacturing.

Session Details: Practical Applications of Machine Learning for the eTMF with Proven Examples 10-11-2021, 9:30 am View In Agenda

Biography: Mark is a research professional with 25 years in drug development, sales leadership, licensing, and program management. Mark’s experience includes an extensive career at Pfizer in R&D, program leadership at the biotech MannKind Corporation, and stints in sales and sales leadership at IQVIA, Covance, and ICON. Mark joined Medidata through the acquisition of MC10 where he was the VP of Sales.  Having earned an honors degree in molecular and cellular from the University of Connecticut, an MBA from Rensselaer Polytechnic Institute, and multiple executive leadership certificates from the Harvard Business School, Mark has been involved in most aspects of drug development throughout his career and is a seasoned corporate leader.

Session Details: PANEL DISCUSSION Is the pharma industry still too conservative with wearable tech? 09-11-2021, 3:45 pm View In Agenda

Biography: Michael Patel is a Senior Scientist II at Novartis Institutes of BioMedical Research in Cambridge, MA. There, he is involved in biomarker planning and implementation on early phase clinical programs and studies across a wide range of therapeutic areas. Specifically, he has been heavily involved in identifying and evaluating near patient sample collection and analysis technologies. This includes engaging and collaborating with internal and external partners on progressing to the ultimate goal of applying these to future decentralized and patient-centric clinical studies.   Michael received a bachelor’s degree from Rutgers University and a doctorate in pharmacy from the University of North Carolina.

Session Details: NOVARTIS DISCUSSION - Diving into the New Era of Patient Centric Micro-Sampling Devices Which Can Fit into New Technologies: How Have These Been Influenced by COVID & the DCT Movement? 09-11-2021, 2:30 pm View In Agenda

Biography: Matt is Vice President of Product at Medidata, leading the Patient Cloud solution for the last 8.5 years. During this time, Matt has led product strategy and overseen development for Medidata's Decentralized Trial capabilities, including eCOA, eConsent, Wearable Sensor and Patient Engagement technologies.  Matt lives in Burlington, VT with his wife and daughter.

Session Details: Empowering Patients in Decentralized Trials with Medidata eCOA 09-11-2021, 10:00 am View In Agenda

Biography: Jess has 15 years of clinical research experience, with much of that time uniquely focused on rare and orphan diseases.  Most recently, Jess oversaw clinical operations at the University of Pennsylvania’s Orphan Disease Center and Gene Therapy Program, both housed within the Perelman School of Medicine. While at Penn, Jess worked closely with biotech companies to implement strategic clinical development initiatives and with thought-leaders to foster collaboration within the rare disease community. She oversaw vendor partnerships to create patient registries and natural history studies, and, most impactfully, she worked hand-in-hand with patient advocacy groups, providing rare disease patients and their families with data-driven guidance while accelerating the clinical research process. Prior to Penn, Jess spent eleven years in the CRO industry with Syneos Health, formerly INC Research, where she held director level positions growing their therapeutic business units, with a specific focus in global rare disease and pediatric trials. Jess earned bachelor’s degrees in both Molecular Biology and Psychology from Meredith College in Raleigh, NC.

Session Details: Creating Effective Patient Recruitment Strategies in Rare Disease Research 09-11-2021, 11:30 am View In Agenda

Biography: Behtash Bahador is an Associate Director at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.

Session Details: This is Not a Trend: Exploring Why Patient-Centered Clinical Research Will Continue to Change the Research Paradigms of the Past and the Impact it Can Have 09-11-2021, 1:30 pm View In Agenda

Biography: Michelle has been employed in the healthcare industry for over 20 years.  Her background includes sales and training for numerous World Renowned medical device and pharmaceutical companies. Michelle joined TrialCard in 2019 as the Director of Business Development where her responsibilities include working with sponsors and CRO’s to provide Clinical Trial Support, Virtual Clinical Supplies and Medical Services and Procedures Reimbursement. The unique and innovative TrialCard model significantly simplifies the clinical supply process by improving study flexibility while reducing costs and activities for the clinical supply and study team.

Session Details: Exploring Innovative Solutions for Today’s Clinical Trial Needs  09-11-2021, 2:00 pm View In Agenda

Biography: Oren Cohen, M.D., joined LabCorp in December 2017 to serve as head of Clinical Pharmacology Services and Chief Medical Officer (CMO). Oren has extensive clinical development experience, most recently from Viamet Pharmaceuticals where he was CMO. He brings more than 30 years of healthcare experience to the role, including several senior medical and operational leadership positions at Quintiles, including Chief Medical and Scientific Officer and global head of Early Clinical Development. Oren received his M.D. from Duke University and served his internship and residency at The New York Hospital, Cornell Medical Center in New York City. He completed his infectious diseases fellowship at the National Institute of Allergy and Infectious Diseases (NIAID), and stayed on to become an investigator in the Laboratory of Immunoregulation where he conducted basic and translational research on the immunopathogenesis of HIV infection. He served on the national antiretroviral guidelines panel and ultimately served as Assistant Director for Medical Affairs for NIAID. Oren has published scientific papers in Science, The New England Journal of Medicine, The Lancet, The Journal of Clinical Investigation, and Proceedings of the National Academy of Sciences, among others. He is a Fellow of the Infectious Diseases Society of America and a Consulting Professor of Medicine at Duke University Medical Center. Email: oren.cohen@labcorp.com

Session Details: CASE STUDY: Accelerated Early Clinical Development of a Potent Direct-Acting Antiviral Agent for COVID-19 09-11-2021, 4:15 pm View In Agenda

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Session Details: Clinical Trial Prescription Services from a Clinical Site Perspective 09-11-2021, 11:30 am View In Agenda

Biography: Samit is an Experienced leader in specialty pharmacy, managed markets, provider network, KOL engagement, and formulary management with contracting expertise under pharmacy and medical benefits. He currently works as Senior Director in Patient Solutions at Myonex.

Session Details: Clinical Trial Prescription Services from a Clinical Site Perspective 09-11-2021, 11:30 am View In Agenda

Biography: Dr. Johnson is a professor of regulatory strategy at Northeastern University and Senior Director of Regulatory Strategy at Roivant Sciences, where she leads IND-enabling strategy for a variety of novel biotech and medtech products. She has over 16 years experience in global clinical trials, and previously held senior clinical and regulatory positions at IQVIA and GE Healthcare. She has authored over 20 publications, including on GCP and clinical trial strategy for medical devices and complex biologic products.

Session Details: PANEL DISCUSSION - Working Through Issues with Your CRO to Stay in Control of Your Study 09-11-2021, 3:45 pm View In Agenda

Biography: Greg is an expert at designing innovative data collection plans, managing quality control of collected data, and creating custom tools and databases for end users, leveraging expertise in clinical software applications including SAS, DataFax, OpenClinica, Excel, and Access.

Session Details: Decentralized Clinical Trials in 30 Minutes 09-11-2021, 2:00 pm View In Agenda

Biography: Sverre Bengtsson started in the clinical trials industry over 30 years ago. He started as a statistician/statistical programmer, later into data management and since over 20 years into business development. He has been working in both CRO’s as well as in clinical trials technology companies, including the global first ePRO company. Sverre is very interested in making clinical trials efficient, in both study design but also in the processes and technologies used.   Sverre co-founded Viedoc Technologies 19 years ago and is responsible for some of the major accounts but also the vision around the company. He’s on the board of both some industry organisations and in clinical technology companies.

Session Details: Decentralized Clinical Trials in 30 Minutes 09-11-2021, 2:00 pm View In Agenda

Biography: A highly experienced Senior Director of Clinical Data Systems with considerable global experience within the CRO and technology environments.  Key experiences are within the US, Indian and all European markets across all phases and multiple therapeutic areas.  Well versed in GDPR, validation, and regulatory requirements across US and EU markets.

Session Details: How the Pandemic Changed EDC functional needs 10-11-2021, 11:00 am View In Agenda